Characteristics of HIV-1 discordant couples enrolled in a trial of HSV-2 suppression to reduce HIV-1 transmission: the partners study
Lingappa, J.R.; Kahle, E.; Mugo, N.; Mujugira, A.; Magaret, A.; Baeten, J.; Bukusi, E.A.; Cohen, C.R.; Katabira, E.; Ronald, A.; Kiarie, J.; Farquhar, C.; Stewart, G.J.; Makhema, J.; Essex, M.; Were, E.; Fife, K.; Debruyn, G.; Gray, G.; McIntyre, J.; Manongi, R.; Kapiga, S.; Coetzee, D.; Allen, S.; Inambao, M.; Kayitenkore, K.; Karita, E.; Kanweka, W.; Delany, S.; Rees, H.; Vwalika, B.; Coombs, R.W.; Morrow, R.; Whittington, W.; Corey, L.; Wald, A.; Celum, C.
PLOS one 4(4): E5272
2009
ISSN/ISBN: 1932-6203 PMID: 19404392 DOI: 10.1371/journal.pone.0005272Document Number: 206994
The Partners HSV-2/HIV-1 Transmission Study (Partners Study) is a phase III, placebo-controlled trial of daily acyclovir for genital herpes (HSV-2) suppression among HIV-1/HSV-2 co-infected persons to reduce HIV-1 transmission to their HIV-1 susceptible partners, which requires recruitment of HIV-1 serodiscordant heterosexual couples. We describe the baseline characteristics of this cohort. HIV-1 serodiscordant heterosexual couples, in which the HIV-1 infected partner was HSV-2 seropositive, had a CD4 count >or=250 cells/mcL and was not on antiretroviral therapy, were enrolled at 14 sites in East and Southern Africa. Demographic, behavioral, clinical and laboratory characteristics were assessed. Of the 3408 HIV-1 serodiscordant couples enrolled, 67% of the HIV-1 infected partners were women. Couples had cohabitated for a median of 5 years (range 2-9) with 28% reporting unprotected sex in the month prior to enrollment. Among HIV-1 susceptible participants, 86% of women and 59% of men were HSV-2 seropositive. Other laboratory-diagnosed sexually transmitted infections were uncommon (<5%), except for Trichomonas vaginalis in 14% of HIV-1 infected women. Median baseline CD4 count for HIV-1 infected participants was 462cells/mcL and median HIV-1 plasma RNA was 4.2 log(10) copies/mL. After adjusting for age and African region, correlates of HIV-1 RNA level included male gender (+0.24 log(10) copies/mL; p<0.001) and CD4 count (-0.25 and -0.55 log(10) copies/mL for CD4 350-499 and >500 relative to <350, respectively, p<0.001). The Partners Study successfully enrolled a cohort of 3408 heterosexual HIV-1 serodiscordant couples in Africa at high risk for HIV-1 transmission. Follow-up of this cohort will evaluate the efficacy of acyclovir for HSV-2 suppression in preventing HIV-1 transmission and provide insights into biological and behavioral factors determining heterosexual HIV-1 transmission. ClinicalTrials.gov NCT00194519.